Sites & Operations
Principal Investigator (PI)
A Principal Investigator (PI) is the qualified physician or other appropriately credentialed professional who has primary responsibility for the conduct of a clinical trial at an investigational site, including protocol adherence, participant safety, data integrity, and regulatory compliance.
U.S. PIs sign FDA Form 1572 attesting to qualifications and commitments. PI obligations are detailed in 21 CFR 312.60; 312.69 and ICH E6(R3) Section 4. Sub-investigators (Sub-Is) perform protocol-specified tasks under the PI's supervision and are listed on the 1572 or delegation log.
PI experience is a major site-selection factor; investigators with prior trials in the indication and clean inspection histories are preferred. Tools like FDA BMIS and clinical trial databases support PI vetting.
Related terms
Site Selection (Clinical Trials)
Site selection is the process by which sponsors and CROs identify, evaluate, and choose the clinical trial sites best suited to enroll a given study, based on patient population access, investigator experience, operational capacity, regulatory standing, and historical performance.
Site Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the on-site or remote evaluation conducted by a sponsor or CRO before site activation, to confirm that a candidate site has the personnel, facilities, processes, and patient access required to conduct the planned clinical trial in compliance with GCP.
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo